• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
510(k) Number K120599
Device Name DEPUY M-SPEC 36MM FEMORAL HEADS
Original Applicant
DEPUY ORTHOPAEDICS
700 orthopaedic drive
correne ramy,  IN  46582
Original Contact correne ramy
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
JDI  
Date Received02/28/2012
Decision Date 04/30/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-